BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1063368 · Received June 19, 2008

    Report

    Report Number
    1222780-2008-00068
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE DEVICE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT A UTERINE ABLATION PROCEDURE WAS PERFORMED IN 2008, USING A DISPOSABLE NOVASURE DEVICE. THE NEXT DAY, "THE PT ARRIVED IN THE [EMERGENCY ROOM] ER COMPLAINING OF ABDOMINAL PAIN...HAD A TEMPERATURE OF 103...[AND] A WHITE CELL COUNT OF 20." THE PT WAS ADMITTED AND "WAS GIVEN IV ANTIBIOTICS." THE "WHILE BLOOD COUNT WAS AT NORMAL LEVEL" AT THE END OF THE DAY. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A SMALL BLOOD CLOT OUTSIDE THE UTERUS AND THE PT WAS "PLACED ON A BLOOD THINNER." CULTURES TAKEN AT THIS TIME WERE NEGATIVE. THE PT WAS DISCHARGED FROM THE HOSP "ONE WEEK FROM ADMITTANCE" WITH A DIAGNOSES OF "FEVER FROM UNKNOWN ORIGIN" AND WAS REPORTEDLY "DOING FINE AT THE PRESENT TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R